Extension Study With FIRMAGON(R) (degarelix) Showed Continued Benefits for Prostate Cancer Patients Beyond One Year

SAN FRANCISCO, June 1, 2010 - Data recently presented on FIRMAGON(R) (degarelix) hormonal therapy for
prostate cancer showed that long-term use beyond one year (median observation
time 840 days) continued to be effective and well tolerated.[1] Full details
were shared at the American Urological Association (AUA) 2010 Annual Meeting.

FIRMAGON(R) is a gonadotropin-releasing hormone (GnRH) receptor blocker
indicated for the treatment of patients with advanced hormone-dependent
prostate cancer. The Phase III extension study beyond one year (CS21A) of the
pivotal FIRMAGON(R) vs leuprolide trial (CS21) was designed to collect
extended safety and tolerability data on FIRMAGON(R). At the end of the CS21
one-year trial, all patients were offered to continue treatment with
FIRMAGON(R), both those originally on FIRMAGON(R) and those who had used
leuprolide (a GnRH agonist).

The main findings were:

    - Efficacy of FIRMAGON(R) was maintained over the full study period
      (median observation time 840 days)[1]

      - In the intent-to-treat (ITT) study population, FIRMAGON(R)
        significantly improved prostate specific antigen (PSA) progression-
        free survival (PFS) compared with leuprolide during the first year of
        therapy. The leuprolide patients, who continued treatment with
        FIRMAGON(R), experienced a significantly lower event rate leading to
        an improved PSA PFS.[1]

    - Tolerability of FIRMAGON(R) was maintained throughout the extended
      study period.[1]

"These data reassure physicians that for the best outcomes when using
FIRMAGON(R) as a therapy for hormone dependent prostate cancer, patients
should start and stay on FIRMAGON(R)," said Dr E. David Crawford, head of
Urologic Oncology, University of Colorado, Denver Health Sciences Center, and
Practice Director for the Urologic Oncology Clinic. "FIRMAGON(R) provides a
fast and sustained reduction in testosterone levels and these new data
indicate that efficacy is maintained over the long-term without any
additional negative effects on tolerability."

Although the extension trial was not specifically designed to test
changing from leuprolide to FIRMAGON(R) after one year, the results suggest
that changing from leuprolide to FIRMAGON(R) improves PSA PFS.[1]

Additional analysis of the safety data from the pivotal Phase III trial
were also presented at AUA. The analysis evaluated the cardiovascular safety
profile of FIRMAGON(R) vs leuprolide. The results showed that there were no
significant differences between the cardiovascular safety profile of the two
treatment groups, and the risk of CV events in both treatment arms was
low.[2]

    - Mean changes in QTcF interval were similar for FIRMAGON(R) and
      leuprolide.
    - Rates of CV adverse events were low and similar for FIRMAGON(R) and
      leuprolide.

Notes to Editors

About Firmagon

FIRMAGON(R) has unique chemical characteristics and a novel mechanism of
action, different from traditionally used hormonal therapies. Administered as
a subcutaneous injection, FIRMAGON(R) rapidly reduces levels of prostate
specific antigen (PSA) within two weeks by immediately blocking the GnRH
receptors in the pituitary gland. Blocking the receptors suppresses the
release of the luteinising hormone (LH) and follicle-stimulating hormone
(FSH), resulting in a decrease in production of testosterone by the testicles
to castration levels within three days. Prostate cancer is dependent on
testosterone for its growth, and reducing testosterone levels slows the
growth of cancer cells.

In clinical studies, FIRMAGON(R) suppressed testosterone and PSA faster
than leuprolide, an existing treatment for advanced prostate cancer.[3]

In clinical trials FIRMAGON(R) was generally well tolerated. Common side
effects are hot flushes, injection site pain and erythema, increased weight,
nasopharyngitis, fatigue and back pain.[3],[4]

About Prostate Cancer

Prostate cancer is the most common form of male cancer in the western
world,[5] and the second leading cause of cancer death in men in some
countries.[6] Around 300,000 new cases of prostate cancer are diagnosed in
Europe each year.[7] Worldwide this figure rises to 670,000 new cases.[7] For
further media information and news alerts on prostate cancer please visit
Ferring's information website www.ProstateCancerLiving.com

About Ferring

Ferring is a Swiss-headquartered, research driven, speciality
biopharmaceutical group active in global markets. The company identifies,
develops and markets innovative products in the areas of urology,
endocrinology, gastroenterology, gynaecology, and fertility. In recent years
Ferring has expanded beyond its traditional European base and now has offices
in over 40 countries. To learn more about Ferring or our products please
visit www.ferring.com.

———————————

References

[1] Crawford, ED, Moul, JW, Shore, ND et al. Switching from leuprolide to
degarelix vs continuous degarelix treatment - effects on long-term
prostate-specific antigen control. Poster and abstract presentation at the
AUA 2010 Annual Meeting, San Francisco, CA, USA: J Urol 2010; 183 (Suppl):
e262, abstract 670
download.journals.elsevierhealth.com/pdfs/journals/0022-5347/PIIS0022534710013133.pdf

[2] Klotz, L, Smith, M, Persson, BE et al. Cardiovascular safety of
degarelix: results from a 12-month, comparative, randomized, open-label,
parallel-group phase III trial in prostate cancer patients. Oral presentation
at the AUA 2010 Annual Meeting, San Francisco, CA, USA: J Urol 2010; 183
(Suppl): e228, abstract 582. Presented by M Smith
www.jurology.com/article/S0022-5347%2810%2901097-9/fulltext

[3] Klotz L, Boccon-Gibod L, Schröder FH et al. The efficacy and safety
of degarelix: a 12-month, comparative, randomized, open-label, parallel-group
phase III study in patients with prostate cancer. BJU Int. 2008;102(11
):1531-1538.

[4] Van Poppel H, De La Rosette JJ, Persson B.E et al. Degarelix Study
Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone
(GnRH) receptor blocker, investigated in a multicentre randomised study in
prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28

[5] University of Iowa Hospitals and Clinics. Available at:
www.uihealthcare.com/topics/medicaldepartments/urology/prostatecancer/index.html
[Accessed 25 May 2010]

[6] American Cancer Society. Available at:
www.cancer.org/docroot/cri/content/cri_2_4_1x_what_are_the_key_statistics_for_prostate_cancer_36.asp
[Accessed 25 May 2010]

[7] Cancer Research UK. Available at:
info.cancerresearchuk.org/cancerstats/types/prostate/index.htm
[Accessed 25 may 2010]

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Media enquiries: Sarah Stanmore, Tonic Life Communications, Tel: +44-207-798-9906, sarah.stanmore at toniclc.com ; Helen Swift, Tonic Life Communications, Tel: +44-207-798-9924, helen.swift at toniclc.com ; Helen Gallagher, Ferring Pharmaceuticals, Tel: +41-58-301-0051, helen.gallagher at ferring.com .